Ignite Creation Date:
2024-05-06 @ 8:44 AM
Last Modification Date:
2024-10-26 @ 12:04 PM
Study NCT ID:
NCT02803775
Status:
COMPLETED
Last Update Posted:
2019-09-26
First Post:
2016-06-07
Brief Title:
Paced And Sensed Electrical Delay in CRT Therapy PASED CRT
Sponsor:
Deborah Heart and Lung Center
Organization:
Deborah Heart and Lung Center
Study Overview
Official Title:
Paced And Sensed Electrical Delay in CRT Therapy PASED CRT
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PASED
Brief Summary:
Cardiac resynchronization therapy CRT is a well established clinical therapy for patients with symptomatic left ventricular systolic dysfunction and electrocardiographic QRS duration of 120 ms or greater Multicenter trials have consistently demonstrated CRT non responder rates of 32-43 at 6 months Subsequent studies have shown that utilizing echocardiographic-guided device reprogramming for optimal atrio-ventricular A-V and interventricular VV delays at rest have improved clinical response Recently an echocardiographically validated automated pacemaker programmer-based intra-cardiac electrogram IEGM algorithm has been developed for rapid optimization of sino-ventricular P-V A-V and V-V delays at resting heart rates that is partially based on the interventricular conduction time delays Nevertheless controversy still persists as to the applicability of both echocardiographic and IEGM derived algorithms at elevated heart rates as with physical activity when patients are more likely to experience symptoms related to poor cardiac output
Recent studies have shown clinical benefits of pacing from sites of late intrinsic activation or intra-ventricular conduction delays IVCD Some studies have utilized the intrinsic SENSED IVCD method while others used the right ventricle RV-PACED IVCD There have not been any studies to date that compare both methods to determine if one may yield a better clinical outcome with lower non-responder rates
This study predicts that the RV paced IVCD method will provide better clinical outcomes than the longest RV sensed IVCD as determined by the clinical composite score
The study is a prospective double blind study with an additional cross-over group consisting only of non-responders to compare the clinical response in 72 patients receiving CRT therapy After successful CRT-D implantation and before hospital discharge patients will be randomly assigned in a 11 fashion to Group 1 SENSED or Group 2 PACED The patient will complete a Minnesota Living with Heart Failure questionnaire compare echocardiographic data and be assessed by a blinded nurse and physician prior to discharge and at each follow up visit to maintain the double blind design
After 3 months of follow-up non-responders from each group will be crossed-over to the other group and followed for an additional 3 months Clinical data will be collected at the end of that 3 months and compared looking at changes in symptoms ejection fraction EF and other echocardiographic measurements New York Heart Assocation Function Class NYHA class clinical composite scores CCC device interrogation data and hospital admissions between the two groups to see if there is a statistical difference
Recent studies have shown clinical benefits of pacing from sites of late intrinsic activation or intra-ventricular conduction delays IVCD Some studies have utilized the intrinsic SENSED IVCD method while others used the right ventricle RV-PACED IVCD There have not been any studies to date that compare both methods to determine if one may yield a better clinical outcome with lower non-responder rates
This study predicts that the RV paced IVCD method will provide better clinical outcomes than the longest RV sensed IVCD as determined by the clinical composite score
The study is a prospective double blind study with an additional cross-over group consisting only of non-responders to compare the clinical response in 72 patients receiving CRT therapy After successful CRT-D implantation and before hospital discharge patients will be randomly assigned in a 11 fashion to Group 1 SENSED or Group 2 PACED The patient will complete a Minnesota Living with Heart Failure questionnaire compare echocardiographic data and be assessed by a blinded nurse and physician prior to discharge and at each follow up visit to maintain the double blind design
After 3 months of follow-up non-responders from each group will be crossed-over to the other group and followed for an additional 3 months Clinical data will be collected at the end of that 3 months and compared looking at changes in symptoms ejection fraction EF and other echocardiographic measurements New York Heart Assocation Function Class NYHA class clinical composite scores CCC device interrogation data and hospital admissions between the two groups to see if there is a statistical difference
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None